Actively Recruiting

Age: 18Years +
All Genders
ID06949150

Combined Coronary CT Angiography and CT Perfusion in Coronary Artery Disease: Integrating Plaque Morphology, Hemodynamics, and Perfusion for Precision Management

Led by Shanghai Zhongshan Hospital · Updated on 2025-04-29

2000

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of combined coronary computed tomography angiography (CTA) and CT myocardial perfusion (CTP) imaging to improve the diagnosis and management of coronary artery disease (CAD). This study addresses the limitations of CTA alone in assessing the functional significance of coronary lesions, especially in cases with borderline stenosis, severe calcification, or coronary microvascular dysfunction. It aims to evaluate the long-term prognostic value of integrating anatomical and functional imaging findings alongside AI-driven analysis to enhance personalized risk assessment and treatment decisions. The study observes patients undergoing either conservative management with medical therapy and lifestyle interventions or invasive coronary angiography (ICA) potentially combined with procedures like percutaneous coronary intervention (PCI), intravascular ultrasound (IVUS), optical coherence tomography (OCT), or fractional flow reserve (FFR). Imaging assessments include detailed plaque characterization and perfusion analysis using AI tools to quantify relevant markers. The research team will monitor clinical decisions influenced by imaging results, such as the need for revascularization or additional testing, and stratify patients into subgroups for further analysis. Participants will be followed over a five-year period to track major adverse cardiovascular events (MACE) and assess the predictive power of combined imaging biomarkers. Diagnostic accuracy of combined CTA/CTP will be compared with invasive reference standards within 30 days. Other evaluations include changes in myocardial perfusion related to symptom relief and the impact of severe calcification on diagnostic performance. The study involves comprehensive data collection on clinical outcomes, imaging metrics, and therapy adjustments to refine non-invasive approaches for CAD management.

CONDITIONS

Brief Title

Combined Coronary CT Angiography and CT Perfusion in Coronary Artery Disease (CoroFusion)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an indication for CT myocardial perfusion imaging (CTP)
  • Patients who have signed a written informed consent form
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than 35%
  • Acute ST-elevation myocardial infarction within the past 3 months
  • Previous coronary artery bypass graft surgery
  • Planned coronary artery bypass graft surgery after diagnostic angiography
  • Poor quality of CTA/CTP images unsuitable for analysis
  • Contraindications for CT perfusion or coronary angiography
  • Pregnancy, cancer, severe valvular heart disease, or liver/kidney dysfunction
  • Other diseases with life expectancy less than one year
  • Inability to sign informed consent or poor compliance likely to prevent study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 30 days

Participants undergo coronary CT angiography (CTA) and CT myocardial perfusion (CTP) imaging to assess coronary artery disease, including plaque characteristics and myocardial blood flow.

1 to 2 visits depending on imaging procedures

Monitoring

Duration - Up to 5 years

Participants are observed and clinical decisions are made based on imaging results, including medical therapy, lifestyle interventions, or invasive coronary angiography with possible interventions.

Periodic visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

W

Wei Gao, PHD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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